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NCT03366142 · ClinicalTrials.gov registry record · Phase 1
Ustekinumab (Anti-IL-12/23p40 Monoclonal Antibody) in Patients With Leukocyte Adhesion Deficiency Type 1 (LAD1) Who Have Inflammatory Pathology
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03366142 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 6 participants.
The verdict
NCT03366142, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Background: The disease leukocyte adhesion deficiency type 1 (LAD1) affects white blood cells. Those are immune system cells. In people with LAD1, white blood cells do not properly communicate with the rest of the body. This causes uncontrolled inflammation, particularly in the gums. People with LAD1 can get frequent infections and tend to lose their teeth before adulthood. Researchers want to see if a drug called ustekinumab helps people with LAD1. Objective: To study the safety and tolerability of ustekinumab in treating gum inflammation in people with LAD1. Eligibility: People ages 12 65 with LAD1 Design: Participants will be screened with: * Medical history * Physical exam * Oral exam * A scan of the chest, abdomen, and pelvis for possible infection * Blood and urine tests The baseline visit will take 2 days. Participants will: * Repeat most screening tests * Have a skin exam * Have small pieces of their gums removed (biopsy) * Have mouth fluids collected * Get the study drug injected under the skin of the abdomen, thigh, or elsewhere on the body. They will be watched for at least 2 hours. Participants will be instructed on tracking how they are feeling and any side effects. Participants will have 4 more visits over 40 weeks. They will get the study drug and repeat the baseline tests. Participants may have up to 5 more tissue biopsies. Participants will be called between visits to discuss how they are feeling and side effects. Participants will have a final visit 52 weeks after the baseline. They will repeat most of the baseline tests. Participants will answer questions about their oral ulcers.
Interventions
- DRUG Ustekinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-07-02 |
| Est. Completion | 2024-10-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03366142
The ClinicalTrials.gov registry entry for NCT03366142 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ustekinumab is the first listed.
NCT03366142 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03366142 about?
NCT03366142 is a clinical study titled "Ustekinumab (Anti-IL-12/23p40 Monoclonal Antibody) in Patients With Leukocyte Adhesion Deficiency Type 1 (LAD1) Who Have Inflammatory Pathology". Background: The disease leukocyte adhesion deficiency type 1 (LAD1) affects white blood cells. Those are immune system cells. In people with LAD1, white blood cells do not properly communicate with the rest of the body. This causes uncontrolled inflammation, particularly in the gums. People with LA...
What is the current status of trial NCT03366142?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2018-07-02. Estimated completion is 2024-10-17.
What interventions are being tested in trial NCT03366142?
The interventions under investigation include: Ustekinumab (DRUG).
Who is sponsoring clinical trial NCT03366142?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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